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Compares treatment options for Breast Cancer
Official title Clinical Study of Camrelizumab Combined With TCb Versus TCb in Neoadjuvant Treatment of Triple-negative Breast Cancer
ClinicalTrials.gov ID: NCT05475678
What this study is testing
What is （Carrelizumab + TCb） regimen?
（Carrelizumab + TCb） regimen is an investigational medicine, being studied as a potential treatment for breast cancer.
Also referred to as Carrelizumab +docetaxel + carboplatin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Triple-negative breast cancer (TNBC) is a special subtype of breast cancer that lacks the expression of ER, PR, and Her-2 proteins, accounting for 15%-20% of all breast cancers.TNBC patients do not benefit from endocrine therapy or HER-2-targeted therapy, but are sensitive to cytotoxic drug therapy.Although the survival of TNBC patients has improved significantly compared with the past, it is still the type with the worst prognosis among all subtypes of breast cancer. Methods and drugs to further improve the therapeutic effect of TNBC patients are still being explored.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70, women only
You may be able to join if
- Age: 18-70 years old
- cT2 - cT4d, or cT1c with axillary lymph node metastasis confirmed clinically and pathologically；
- Pathologically proven triple negative breast cancer: Triple-negative breast cancer is defined as:
- Negative for ER and PR (IHC nuclear staining \<10%)
- Her-2 negative (IHC 0, 1+ without FISH, or IHC 2+ with no amplification by FISH)；
You likely can't join if
- The patient has evidence of metastatic breast cancer；
- For this disease, chemotherapy, endocrine therapy, targeted therapy, radiation therapy, etc. have been received;
- The patient has a second primary malignancy other than adequately treated skin cancer;
- The patient has been treated with anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death ligand 1 (anti-PD-L1) or anti-PD-L2 drugs...
- The patient has been diagnosed with immunodeficiency disease or autoimmune disease;
- The patient has severe lung or heart disease;
See the full eligibility criteria
- Age: 18-70 years old
- cT2 - cT4d, or cT1c with axillary lymph node metastasis confirmed clinically and pathologically；
- Pathologically proven triple negative breast cancer: Triple-negative breast cancer is defined as:
- Negative for ER and PR (IHC nuclear staining \<10%)
- Her-2 negative (IHC 0, 1+ without FISH, or IHC 2+ with no amplification by FISH)；
- Has clinically measurable lesions:Measurable lesions on ultrasound, mammography, or MR (optional) within 1 month before randomization；
- Organ and bone marrow function tests within 1 month before chemotherapy suggest no contraindications to chemotherapy；
- Cardiac ultrasound EF value ≧55%；
- Females of childbearing age, with a negative serum pregnancy test 14 days before randomization;
- ECOG score≤1 point;
- Sign informed consent；
- The patient has evidence of metastatic breast cancer；
- For this disease, chemotherapy, endocrine therapy, targeted therapy, radiation therapy, etc. have been received;
- The patient has a second primary malignancy other than adequately treated skin cancer;
- The patient has been treated with anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death ligand 1 (anti-PD-L1) or anti-PD-L2 drugs, or other immunotherapy；
- The patient has been diagnosed with immunodeficiency disease or autoimmune disease;
- The patient has severe lung or heart disease;
- The patient has active hepatitis B and C;
- The patient has a history of organ transplantation or bone marrow transplantation;
- pregnant or breastfeeding women;
- The investigators considered chemotherapy contraindicated due to serious, uncontrolled other medical conditions.
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, Henan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.